Understanding genetic changes in metastatic pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to better understand metastatic pancreatic ductal adenocarcinoma (PDAC) by analyzing genetic changes in tumor samples and blood from patients undergoing first-line chemotherapy. Researchers will collect fresh tumor biopsies and blood samples to perform comprehensive genomic analyses and assess how these genetic characteristics correlate with treatment responses. The study will include 190 patients and will focus on those receiving either FOLFIRINOX or gemcitabine and nab-paclitaxel regimens. The goal is to identify potential biomarkers that could guide personalized treatment strategies in the future.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histological and/or radiological diagnosis of metastatic PDAC. Patients without a histological diagnosis of PDAC must undergo confirmatory tumour biopsy prior to treatment start date.
* Planned for first-line systemic therapy with FOLFIRINOX or GP, either in routine care or in combination with an investigational agent(s) within a clinical trial.
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate organ function
* Life expectancy of \> 90 days as judged by the investigator
* Ability to give informed consent
* Measurable disease by RECIST 1.1
* Presence of a tumour lesion amenable to core needle biopsy as judged by a staff interventional radiologist. A minimum of 3 tumour cores must be safely obtainable under CT or US guidance.
* Fit enough to safely undergo a tumour biopsy as judged by the investigator
* Ability to lie supine for \> 60 minutes

Patients in the archival cohort must also fulfil the following criteria:

* Archival tumour sample available (either a previous tumour diagnostic biopsy or resection specimen)

Exclusion Criteria:

* Absence of distant or lymph node metastases. Patients with borderline resectable or locally advanced PDAC are not eligible.
* Received prior systemic therapy (chemotherapy or any other anti-cancer agent) in the advanced setting. Patients who received adjuvant chemotherapy after surgical resection of early stage disease are eligible.
* Currently receiving anti-cancer therapy (chemotherapy or any other anti-cancer agent)
* Not fit for combination chemotherapy as judged by the investigator
* Presence of brain metastases
* Female patients with positive pregnancy test
* Patients who are not safe to include in the study as judged by the investigator for any medical or non-medical reason
* Unable to comply with study assessments and follow-up

Where it's running

• BC Cancer - Vancouver
  Vancouver, British Columbia, Canada Recruiting
• Tom Baker Cancer Centre
  Calgary, Alberta, Canada Completed
• Cross Cancer Institute
  Edmonton, Alberta, Canada Withdrawn
• The Ottawa Hospital
  Ottawa, Ontario, Canada Active not recruiting

Study contacts

• Principal investigator: Daniel J Renouf, MD — BC Cancer
• Study coordinator: Daniel J Renouf, MD
• Email: drenouf@bccancer.bc.ca
• Phone: 800-663-3333

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Integrated genomic and clinical database for cancer biomarker discovery

  Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.

  Recruiting Samsung Medical Center · Seoul, Gang-Nam · NCT07911267

• Using contrast-enhanced ultrasound to check for local pancreatic cancer recurrence after surgery

  This pilot test uses contrast-enhanced ultrasound to see if it can help detect return of pancreatic cancer after surgery in patients being watched with CT scans.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07910383

• Combination of ivermectin with standard skin-protective care for daraxonrasib-related skin toxicity in pancreatic cancer

  This study tests whether adding ivermectin to standard preventive skin care helps people with pancreatic cancer who develop skin side effects from daraxonrasib.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07895498

• Becotatug Vedotin Plus Anti-PD-1 and S-1 in EGFR-Positive Advanced Pancreatic Cancer

  This study tests a three-drug regimen (becotatug vedotin, an anti-PD-1 therapy, and S-1) in adults with EGFR-positive advanced pancreatic cancer who have not responded to at least one prior therapy.

  Recruiting Ningbo Medical Center Lihuili Hospital · Ningbo, Zhejiang · NCT07892573

• Blood protein biomarkers to help diagnose pancreatic cancer in adults

  This study tests whether blood protein biomarkers can help detect pancreatic ductal adenocarcinoma and tell it apart from chronic pancreatitis and mucinous pancreatic lesions, and whether combining markers with CA 19-9 improves accuracy.

  Recruiting Grigore T. Popa University of Medicine and Pharmacy · Iași · NCT07875582

• Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Cancer (Phase 1)

  This early-stage study tests whether giving Lm-LLO-TT directly into the belly with low-dose gemcitabine is safe and tolerable for adults with previously treated, unresectable or metastatic pancreatic cancer.

  Recruiting Phase 1 Matter Bio, Inc. · The Bronx, New York · NCT07828236

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.